The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning

Schizoaffective Disorder Clinical Trial

— Galantamine  

Official title:

The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566735
• Other study ID #: 2004-P-001051
• Secondary ID: GAL-EMR-4005
• Status: Completed
• Phase: Phase 3
• First received: December 3, 2007
• Last updated: November 2, 2012
• Start date: July 2004
• Est. completion date: January 2008

Study information

• Verified date: November 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat problems with thinking and memory caused by electroconvulsive therapy (ECT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Criteria to enter the study include males and females between the ages of 18-90 (females must be post menopausal) and a DSM-IV diagnosis of Major Depressive Disorder, Major Depressive Disorder with psychotic features, Bipolar Disorder, depressed type, or Schizoaffective Disorder, depressed type (19).

Exclusion Criteria:

• DSM-IV diagnoses of dementia and its subtypes

• Substance use disorder (active use within the last 6 months)

• Organic mental disorders; seizure disorder

• Unstable physical disorder or physical disorder judged to significantly affect the central nervous system function

• A heart rate of <60

• A systolic blood pressure < 90

• Heart block

• Pre-existing sick-sinus

• Chronic treatment with beta blockers

• Any cardiac arrythmia

• Hypotension

• Coronary artery disease

• Liver and renal function impairment

• Urge incontinence, colitis Crohn's disease, GI motility disorders, asthma and COPD

• Treatment with anti-cholinergic and cholinomimetic medications; and

• Female patients who are pregnant.

• Additionally, women subjects must be postmenopausal, surgically sterile, or using prescription oral contraceptives (e.g. estrogen-progestin combinations) , contraceptive implants (e.g. NorplantTM, DepoProveraTM ), or transdermally delivered contraceptives (Ortho EvraTM) before entry and throughout the study; and have a negative serum b-HCG pregnancy test at screening.

Note: Abstinence and the use of double barrier contraceptive methods are not acceptable in this study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Psychotic Disorders
• Schizoaffective Disorder

Intervention

Drug:
• Razadyne
The starting dose of study medication is 4 mg twice a day
• Placebo
4 mg, 2 times a day

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Ortho-McNeil Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Side Effects	This measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting.	Participants were followed for the duration of hospital stay, an average of 3 weeks	No
Secondary	Cognitive Functioning	This measure refers to participants' scores on the Delayed Memory Index (DMI) compared from baseline (before first ECT) to discharge (after last ECT). The score can range from 40 to 137. The higher the score, the better, in terms of cognitive functioning.	Participants were questioned at baseline and after their last electroconvulsive therapy treatment	No
Secondary	Baseline Depressive Symptoms	This measure refers to the Hamilton Rating Scale for Depression-17 scores (HAM-D-17) which can range from 0 to 50, with <7 referring to mild-to-no depression, and >23 referring to severe depression.	Participants were questioned at baseline	No